FDAnews is pleased to announce its new interactive workshop — Innovative Process Validation Strategies for Medical Devices: Proving Your Processes and Documentation to the FDA

This workshop, taught by internationally renowned medical device process validation expert Dan O'Leary, has been designed to provide attendees with industry best practices to achieve sustainable process validation with regulatory bodies around the world.

Mr. O'Leary has been successfully helping devicemakers large and small conduct and document process validation for more than 20 years. He's a bona-fide, "been there, done that" instructor.

Rather than sitting through two days of endless PowerPoint slides, this one-of-a-kind workshop breaks into small groups and features 15 interactive exercises. Attendees will learn the theories of process validation and documentation and how to put them into practice.

Attendees will learn proven techniques that include:

How to set process validation parameters: participants will analyze a hypothetical process to determine the input parameters and whether the process should be validated.

Best practices for determining the number of records to inspect, when an FDA investigator asks for records, the number reviewed is determined by a sampling plan in QSIT. This exercise explains how the investigator classifies the records, and estimates the error rate; it is not Z1.4 acceptance sampling.

The proper use of a supplied IQ Checklist: participants will use an example in the GHTF guidance document to determine if all the essential elements for Installation Qualification (IQ) are covered.

How to set up an SPC chart and the proper way to monitor a process: this exercise sets up the control lines to use in x-bar & R charts.

Tips and tricks to determine a DOE alias: in fractional factorial DOE, some of the results have an alias. This exercise shows how to determine the aliases in a design.

Applying HACCP Principles: HACCP is a powerful tool that is underutilized in process validation. This exercise demonstrates its application to a process.

Plus 9 more immediately useful exercises to can take back and implement.

Who Will Benefit:

Project managers involved in design and development

Design engineers

Quality engineers

Manufacturing engineers

Quality auditors

Production managers

Production supervisors

Scientists involved in device R&D and manufacturing

Training personnel

General/corporate counsel

Production engineers

Risk management specialists

Meet the Instructor:Dan O'Leary has more than 30 years' experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices and clinical labs. Dan is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics, is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

About FDAnewsFDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.